Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: the primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by evinacumab intravenously (iv) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (hofh). the secondary objectives of the study are to evaluate the effect of evinacumab iv on other lipid parameters, evaluate the effect of evinacumab on ldl-c goal attainment, assess the effect of evinacumab on eligibility for apheresis (using german and us apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with hofh, assess the pharmacokinetics (pk) of evinacumab in patients with hofh and evaluate the potential development of anti-evinacumab antibodies.


Eligibility criteria:
key inclusion criteria: 1. diagnosis of functional hofh 2. if undergoing ldl apheresis, must have initiated ldl apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks 3. willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study key exclusion criteria: 1. ldl-c level \<70 mg/dl (1.81 mmol/l) at the screening visit 2. background medical lipid modifying therapy (lmt) (if applicable) that has not been stable before the screening visit 3. lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit 4. use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit 5. presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins 6. newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (hba1c \>9%) diabetes 7. history of a mi, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit 8. pregnant or breastfeeding women 9. sexually active women of child bearing potential (wocbp), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug 10. men who are sexually active with women of child bearing potential (wocbp) and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last dose of study drug regardless of vasectomy status note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hofh
continuous cardiorespiratory monitoring in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (pex). wearable devices could provide a way for long-term monitoring of disease progression and early signs of pex to intervene as early as possible, thereby improving long-term outcomes. this in-hospital feasibility study will assess the ability of byteflies sensor dots to collect relevant cardiorespiratory data in people with cf and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * confirmed cf diagnosis as determined by a sweat chloride ≥ 60 mmol/l or the presence of two known disease-causing mutations exclusion criteria: * inability to provide written informed consent * a known allergy to any of the used medical adhesives * presence of any type of electronic implanted medical device

Keywords: wearable cardiorespiratory monitoring digital medicine
clinical study of stent versus direct atherectomy to treat arteriosclerosis occlusive disease of lower extremity

Conditions: Atherosclerosis; Ischemia

Summary: this is a randomized study comparing stent and plaque excision systems in treatment of arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

this is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Eligibility criteria:
patients were included if they were de novo stenosis\>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (rutherford-becker class ii-iii) or critical limb ischemia (rutherford-becker class iv-v). they were excluded if they had one or more of the following: 1. acute or subacute lower limb ischemia; 2. severe calcification lesions; 3. total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root; 5. previously lower extremity intervention or surgical graft artery bypass; 6. severe renal insufficiency, creatinine level greater than 2.5 mg/dl; 7. the patient's platelet count is less than 100,000/ul, antiplatelet or anticoagulant contraindications to required medications; 8. patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. unwillingness to return for future follow-up visits

Keywords: stents atherectomy femoral artery popliteal artery
vildagliptin versus glimepiride in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.

1. approval will be obtained from research ethics committee of faculty of pharmacy, damanhour university. 2. all participants agreed to take part in this clinical study and provide informed consent. 3. patients with uncontrolled dm type 2 who are on metformin will be enrolled from endocrinology clinic at damanhour general hospital. 4. serum samples will be collected for measuring the biomarkers. 5. all enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group i will receive vildagliptin as an add-on therapy while group ii will receive glimepiride. 6. all patients will be followed up during 12 week period. 7. at the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment. 8. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. measuring outcome: the primary outcome is the change of serum levels of the measured markers after 12 weeks. 10. results, conclusion, discussion and recommendations will be given. methodology * copeptin and nt-probnp will be determined by elisa. * lipid profile will be measured. * fasting blood glucose and insulin will be measured and homa-ir will be calculated for all subjects. * body weight and blood pressure will be measured. * hba1c will be measured.

Eligibility criteria:
inclusion criteria • 70 uncontrolled adult patients with type ii-diabetes mellitus exclusion criteria * hepatic impairment. * active malignancy. * planned surgical intervention. * any signs of hypersensitivity or contraindication to study drugs developed. * addition of any anti-diabetic medications or insulin during follows up. * chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection). * pregnancy, lactation or child-bearing potential. * cardiac disease. * renal impairment. * history of t1dm, siad, or diabetes insipidus. * therapy with any diuretic or a medication affecting the raas.
branched-chain aminoacids in sleep apnea syndromes (arsas)

Conditions: Sleep Apnea

Summary: the initial hypothesis is that branched-chain aminoacids (bcaa) administration could be beneficial to patients suffering from sleep apnea syndrome (sas), the aim of the present work is to verify this hypothesis. the literature data demonstrate that a bcaa complementation improves the physical performances, protects lean mass and increases vo2 max during training. we demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.


Eligibility criteria:
inclusion criteria: * adult with healthy mind, who has attained his majority, and affiliated to social security. * patient suffering from sas confirmed by polysomnography (psg). * written informed consent form signed. exclusion criteria: * patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study. * patients suffering for severe sas : those who have a number of iah higher than 30 in a validated sleep hour, will be excluded for security reasons. * pregnant women, nursing mothers or women susceptible to procreate without efficient contraception. * patient presenting hypersensitivity to understudying products and their excipients.
the reshape-hf1-fu study

Conditions: Mitral Valve Insufficiency

Summary: to evaluate the safety and efficiency of the mitraclip system in the treatment of patients with clinically significant mitral regurgitation with new york heart association (nyha) functional class ii to iv chronic heart failure.

the purpose of the reshape-hf1-fu study is to follow up the safety and effectiveness of the mitraclip system in the treatment of clinically significant functional mitral regurgitation (fmr) in patients with new york heart association (nyha) functional class iii or iv chronic heart failure, former participants in the reshape-hf trial (abbott vascular).

Eligibility criteria:
inclusion criteria: * former participant in the reshape-hf trial (abbott vascular) * subject agrees to return for all required follow-up visits * the subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's ethics committee exclusion criteria: * withdrawal of informed consent * subject belongs to a vulnerable population
comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without uterine manipulator

Conditions: Endometrial Cancer

Summary: comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator


Eligibility criteria:
inclusion criteria: * patients suitable for laparoscopic surgery patients ages 18-75 patients diagnosed figo stage 1 and 2 endometrial cancer exclusion criteria: * patients not suitable for laparoscopic surgery patients diagnosed figo stage 3 and 4 endometrial cancer pregnant patients
a subject treatment preference study of tivozanib versus sunitinib in subjects with metastatic rcc

Conditions: Metastatic Renal Cell Carcinoma

Summary: randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic rcc who have received no prior systemic therapy for renal cell carcinoma (rcc).

this is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic rcc who have received no prior systemic therapy for renal cell carcinoma (rcc). approximately 160 subjects will be stratified for ecog score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. the study consists of two 12-week treatment periods with a 1-week washout in between. subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. the study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/qol.

Eligibility criteria:
inclusion criteria: * unresectable mrcc * histologically or cytologically confirmed rcc of any histology * subjects with or without prior nephrectomy * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * any prior systemic therapy for treatment of mrcc (including investigational or licensed drugs that target vegf or vegf receptors/pathway, or are mammalian target of rapamycin \[mtor\] inhibitors) * central nervous system malignancies or metastases * significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders * significant serum chemistry or urinalysis abnormalities * significant cardiovascular disease, including symptomatic left ventricular ejection fraction or baseline lvef of ≤ institutional lower limit of normal, uncontrolled hypertension, myocardial infarction or severe angina within 6 months prior to administration of first dose of study drug, history of class iii or iv congestive heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or coronary or peripheral bypass graft within 6 months of screening * corrected qt interval (qtc) of \>480 msec using bazett's formula * currently active second primary malignancy

Keywords: tivozanib hydrochloride renal cell carcinoma subject preference quality of life
population pharmacokinetics and safety of oral posaconazole in children with leukemia

Conditions: Leukemia, Acute

Summary: this study is designed to evaluate the safety, efficacy and population pharmacokinetics of oral posaconazole in children with leukemia.

posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.the purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.

Eligibility criteria:
inclusion criteria: * 1、patients age 2-14 years with acute leukemia (aml, all) undergoing chemotherapy and neutropenia expected to last at least 7 days. 2、karnofsky/lansky score of 60% or greater. 3、defined as alanine transaminase (alt) \<3 x upper limit of normal (uln),aspartate aminotransferase (ast) \<3 x uln; serum bilirubin and alkaline phosphatase \<2 x uln. 4、no other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc. 5、able to take oral medication or take medication via enteral feeding tube. 6、ability to give informed consent. 7、no history of anaphylaxis attributed to the azole class of antifungal agents. exclusion criteria: * 1、existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction. 2、subject is not considered eligible for this clinical research program with posaconazole. 3、use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.
randomized study of digital life coaching in myeloma patients undergoing transplantation

Conditions: Multiple Myeloma; Stem Cell Transplant

Summary: autologous stem cell transplantation (sct) is the standard of care for fit multiple myeloma (mm) patients; however, the first 100 days after sct are marked by extensive life disruptions. we have found a 56% relative increase in the use of high-risk benzodiazepine and z-class (b/z) drugs for anxiety and insomnia among mm patients during this period. digital life coaching (dlc), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. this study will investigate whether peri-sct dlc can lower b/z usage and improve patient-reported well-being.

this is a single-center, phase ii randomized study of mm patients comparing 16 weeks of dlc access versus quasi-usual care (quasi-usual because both arms will receive generic wellness-related electronic handouts alongside requests for patient-reported outcome (pro) assessments). primary objective: to evaluate dlc's impact on b/z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or cinv) secondary objectives: 1. to evaluate dlc's impact on patient-reported general quality of life every 1-2 weeks 2. to evaluate dlc's impact on patient-reported psychosocial distress every 1-2 weeks 3. to evaluate dlc's impact on patient-reported insomnia every 1-2 weeks exploratory objectives: 1. to explore dlc's impact on rates of communications between patients and their treatment teams 2. to explore dlc's impact on clinical outcomes participants may continue study treatment (dlc platform access) for 16 weeks from the time of initiating treatment. participants will not be contacted by the dlc platform vendor after this point. patients will be followed up at day +101 after sct, corresponding to approximately 3 months after sct.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of one of the following (all referred to as multiple myeloma (mm) for the purposes of this protocol): * multiple myeloma (icd-10 code: c90.0) * extramedullary plasmacytoma (icd-10 code: c90.2) * planned receipt of autologous stem cell transplantation (sct) at university of california, san francisco (ucsf) * patients undergoing outpatient sct will be eligible * patients who received chemomobilization will be eligible * ability to understand a written informed consent form (icf) document, and the willingness to sign the icf document exclusion criteria: * age \< 18 years * sct as salvage therapy * patient-assessed lack of sufficient english proficiency * lack of ownership of a personal smartphone

Keywords: digital life coaching multiple myeloma stem cell transplantation
the effectiveness and mechanism study of auricular needling in treating cancer induced anorexia

Conditions: Anorexia Nervosa; Cancer

Summary: controlling of cancer induced anorexia is highly demanded by advanced cancer patients. it plays an important role in improving the quality of life among advanced cancer patients. through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and kps between the auricular needling treating group and control group before and after the treatment. based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.

patients will be recruited from xiyuan hospital. in this study, eligible participants will be randomly assigned to two groups. in the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). conventional nutrition support and symptomatic treatment are given at the same time. in the control group, patient just receive conventional nutrition support and symptomatic treatment. the simple appetite questionnaire, a symptom based anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. other observation index include weight, kps, appetite and the expectation of patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of malignant cancer of stage iii or iv * meet the diagnosis criteria of cancer induced anorexia * karnofsky performance status(kps) score≥ 60 * expected survival time≥3 months * willing to give informed consent * able to comply with trial protocol exclusion criteria: * have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value * obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes * who are receiving progesterone, glucocorticoid or other hormone therapy * those who are participating in other trials. * pregnant women, nursing mother or psychotic patients

Keywords: auricular needling mechanism study anorexia cancer
pharmacokinetic interaction between nevirapine and saquinavir-sgc in hiv-1 infected patients

Conditions: HIV Infections

Summary: the objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. this study will also evaluate the pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical controls treated with nevirapine but without saquinavir-sgc.


Eligibility criteria:
inclusion criteria: * male or female patients between the ages of 18 and 65 years who are seropositive for hiv-1 antibody by an elisa test and confirmed by an alternative method, e.g. western blot * patients who meet the following laboratory parameters: * granulocyte count ≥ 1000 cells/mm3 * hemoglobin ≥ 9.0 g(dl (men and women) * platelet count ≥ 75,000 cells/mm3 * alkaline phosphatase ≤ 3.0 times the upper limit of normal * serum glutamic oxalo-acetic transaminase (sgot) and serum glutamic pyruvic transaminase (sgpt) ≤ 3.0 times the upper limit of normal * total bilirubin ≤ 1.5 times the upper limit of normal * patients receiving a stable antiretroviral regimen, including saquinavir-sgc (fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1 * female patients of childbearing potential must be willing to use a reliable form of contraception, which should include a medically approved form of barrier contraception * patients able to provide written informed consent and comply with study requirements * patients with a viral load less than 400 copies/ml exclusion criteria: * female patients who are pregnant or breastfeeding * patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. such substances in these categories include macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin * patients with previous exposure to (or are currently being treated with) non-nucleoside reverse transcriptase inhibitors (nnrtis) * patients receiving a protease inhibitor other than saquinavir-sgc (fortovase®) in the 28 days prior to visit 1 * patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment in the 12 weeks prior to visit 1 * patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake * patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year) * patients undergoing treatment for an active infection * patients who are heavy smokers (≥ 20 cigarettes or cigars per day)